It is expected that two bioequivalent
drug formulations have comparable in vivo performances and, therefore, share a common optimized dose regimen and an identical clinical efficacy and safety profile (5,6).
It is engaged in bioequivalent
ACCU-BREAK product development through a joint venture with Strides Arcolab Ltd.
Products launched in 2006 include Simvastatin tablets, AB-rated and bioequivalent
to Merck's Zocor; Pravastatin Sodium tablets, AB-rated and bioequivalent
to Bristol-Myers Squibb's Pravachol; Sertraline Hydrochloride tablets, AB-rated and bioequivalent
to Pfizer's Zoloft tablets; Ondanstron injection, AB-rated and bioequivalent
to GSK's Zofran; Budeprion XL (Bupropion HC1 ER tablets), AB-rated and bioequivalent
to Boehringer Ingelheim's Mobic.
The Citizen Petition also addresses the requirement that the labeling for a bioequivalent
product be substantially identical to that of the approved branded product.
Recently launched products include simvastatin tablets USP, AB rated and bioequivalent
to Merck's Zocor; sertraline HCl Tablets, AB rated and bioequivalent
to Pfizer's Zoloft; pravastatin sodium tablets, AB rated and bioequivalent
to Bristol-Myers Squibb's Pravachol; deferoxamine mesylate for injection, USP, AP rated to Novartis' Desferal; desmopressin acetate tablets, AB rated and bioequivalent
to Aventis' DDAVP tablets; and zonisamide capsules, AB rated and bioequivalent
to Dainippon's Zonegran.
generics, which represented around 2.
The product is bioequivalent
to Ovation Pharmaceuticals Ine.
The traditional proliferation of non-bioequivalent
, branded generic or copycat products is slowly being replaced by the steady introduction of bioequivalent
generics in Latin America.
Since the beginning of 2003 Teva USA has introduced 24 new products to the market, among them Tamoxifen Citrate tablets, AB rated and bioequivalent
to AstraZeneca PLC's Nolvadex; Budprion SR and Buproban (Bupropion HCI extended-release tablets), AB rated and bioequivalent
to GlaxoSmithKline PLC's Wellbutrin SR and Zyban, respectively; and Oxycodone HCI extended-release tablets, AB rated and bioequivalent
to Purdue Pharma LP's OxyContin.
When a branded product loses patent protection, bioequivalent
generic versions of the original compound can be launched by competitors, invariably at a lower price; this leads to strong competition for the branded product, which then experiences declining sales and market share.
Since the beginning of 2002 Teva has introduced 15 products to the market, including AB-rated versions of amoxicillin and clavulanate potassium tablets, the bioequivalent
of GlaxoSmithKline's anti-infective drug Augmentin; nizatidine capsules, bioequivalent
to Eli Lilly and Co.
This is a win-win relationship and provides us with the first candidate, targeting colon cancer, to enter our SuperAntibody Bioequivalent